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Aquestive Therapeutics Updates Anaphylm Regulatory Status Following FDA Letter While Advancing International Approval Efforts

Benzinga·01/09/2026 12:08:19
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  • Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time 
  • Receives confirmation from FDA that Agency's review of Anaphylm NDA application is ongoing and no final FDA decision has been made
  • Progresses global regulatory expansion activities in Canada, Europe, and the United Kingdom for Anaphylm
  • Unaudited cash and cash equivalents of approximately $120 million as of December 31, 2025